China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced receiving approval from the ethics committee at the first hospital of Jilin University to initiate a Phase I clinical study for its drug candidate GST-HG121. This molecule is a hepatitis B surface antigen (HBsAg) inhibitor developed for treating hepatitis B virus (HBV) infections.
Mechanism and Preclinical Results
GST-HG121 is a novel small-molecule HBV surface antigen inhibitor that works by destabilizing and degrading HBV mRNA to block the virus. It has demonstrated inhibitory effects on HBV-DNA and HBeAg, with therapeutic benefits on multiple virological indicators. In vivo pharmacodynamic experiments in animals showed an obvious inhibitory effect on HBsAg, alongside a good safety profile in preclinical toxicology studies.
Intellectual Property and Pipeline
GST-HG121 holds compound invention patent authorizations in China, Japan, South Korea, Europe, and other regions. The drug first entered clinical studies for chronic hepatitis B (cHBV) in August 2020. Cosunter’s pipeline also includes another HBsAg inhibitor, GST-HG131, which received approval for clinical studies in March and is hailed as China’s first of its kind. Additionally, the HBV core protein inhibitor GST-HG141, viewed as potentially complementary to both GST-HG131 and GST-HG121, received tacit trial approval in November 2019.-Fineline Info & Tech